The purpose of this study is to determine the effect of the intensive insulin therapy on coagulation and fibrinolysis in patients affected by severe sepsis and septic shock. As a secondary endpoints the investigators will determine the effect of intensive insulin therapy on organ dysfunction and mortality of these patients.

The primary end-point is the evaluation of the activation/deactivation of the fibrinolytic system in the two randomization group [ Time Frame: At Baseline and every 24 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the different organ dysfunctions (pulmonary, hepatic and volemic status) [ Time Frame: 28 days survival ] [ Designated as safety issue: No ]

The effect of the treatment [ Time Frame: 28 days survival ] [ Designated as safety issue: No ]

Sepsis associated to hypotension despite adequate fluid resuscitation, with hypoperfusion including lactic acidosis, oliguria and acute alteration of consciousness. The hypotension does not need to be present in patients treated with inotropic or vasoactive drugs.

Exclusion Criteria:

Age below 16 years

Patients with hematologic malignancy or bone marrow transplant

Patients with type I diabetes

Patients with expected early death because of underlying disease.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00159952